Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by West Pomeranian Cancer Center
Sponsor:
Collaborator:
Pomeranian Medical University Szczecin
Information provided by (Responsible Party):
Bartosz Dąbek, West Pomeranian Cancer Center
ClinicalTrials.gov Identifier:
NCT02065908
First received: February 15, 2014
Last updated: March 22, 2014
Last verified: March 2014
  Purpose

In the proposed project the investigators will asses whether changes in expression of selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines

Resource links provided by NLM:


Further study details as provided by West Pomeranian Cancer Center:

Primary Outcome Measures:
  • Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria [ Time Frame: up to 76 weeks after chemotherapy conclusion ] [ Designated as safety issue: Yes ]
    either a cardiomyopathy with decreased left ventricular ejection fraction (LVEF), a reduction of LVEF ≥5% to <55% with symptoms of heart failure (e.g. orthopnoea and paroxysmal nocturnal dyspnoea, elevated jugular venous pressure, S3 gallop, Hepatojugular reflux, tachycardia), or an asymptomatic reduction of LVEF ≥10% to <55%


Biospecimen Retention:   Samples Without DNA

5 ml of blood will be collected, 2ml of serum will be isolated from the blood and stored below -80C till completion of the study.


Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Blood will be taken

  1. before anthracycline based chemotherapy administration
  2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
  3. after anthracycline chemotherapy cessation
  4. 6 months after chemotherapy cessation if an end point occurs
  5. 12 months after chemotherapy cessation if an end point occurs

Echocardiography will be performed

  1. before anthracycline based chemotherapy administration
  2. after anthracycline based chemotherapy cessation
  3. 6 months after anthracycline based chemotherapy cessation
  4. 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier The investigators will perform high-throughput miRNA(microRNA) expression profiling of serum samples - called training set.

Training set will consist of sera of 30 patients who has reached an end point. Training set will be sequenced using next generation sequencing.

Training set will be used to derive a miRNA signature capable of separating early cardiotoxicity patients from healthy ones. MiRNA signature will be validated using validation set.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.

Criteria

Inclusion Criteria:

  • age 18-70
  • stage I-III TNM (Tumor Node Metastases)

Exclusion Criteria:

  • second or next cancer (except for basal cell skin cancer and CIN)
  • previously treated with chemotherapy
  • previously treated with radiotherapy
  • acute myocardial infarction
  • heart failure
  • cardiomyopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065908

Contacts
Contact: Bartosz Dąbek, MD bdabek@onkologia.szczecin.pl
Contact: Paweł Stachowiak, MD stachowiak22@gmail.com

Locations
Poland
Clinical Oncology Department, West Pomeranian Cancer Center Recruiting
Szczecin, West Pomeranian, Poland, 71-730
Contact: Bartosz Dąbek, MD    +4891 4251500    bdabek@onkologia.szczecin.pl   
Principal Investigator: Bartosz Dąbek, MD         
Pomeranian Medical University, Department of Cardiology Recruiting
Szczecin, Poland, 70-111
Contact: Paweł Stachowiak, MD    +48914661378    stachowiak22@gmail.com   
Principal Investigator: Paweł Stachowiak, MD         
Sponsors and Collaborators
West Pomeranian Cancer Center
Pomeranian Medical University Szczecin
Investigators
Principal Investigator: Bartosz Dąbek, MD West Pomeranian Cancer Center
  More Information

No publications provided

Responsible Party: Bartosz Dąbek, MD, West Pomeranian Cancer Center
ClinicalTrials.gov Identifier: NCT02065908     History of Changes
Other Study ID Numbers: ZCO-2014-BD
Study First Received: February 15, 2014
Last Updated: March 22, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by West Pomeranian Cancer Center:
breast cancer
anthracyclines
cardiotoxicity
circulating microRNA
biomarker
serum
anthracyclines based chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014